Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radiometer America, Inc. — Predicate Candidate Screening
50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
222 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verifica | Radiometer America, Inc. | 2016-01-28 | 35 | 0 |
| K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE | Radiometer America, Inc. | 2000-01-10 | 138 | 4 |
| K991417 | ABL 735 ANALYZER | Radiometer America, Inc. | 1999-11-24 | 215 | 2 |
| K982928 | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM | Radiometer America, Inc. | 1999-01-06 | 139 | 2 |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOL | Radiometer America, Inc. | 1998-02-09 | 26 | 5 |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | Radiometer America, Inc. | 1998-01-28 | 13 | 0 |
| K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | Radiometer America, Inc. | 1998-01-16 | 24 | 1 |
| K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | Radiometer America, Inc. | 1997-10-06 | 28 | 0 |
| K962158 | PICO MODELS 30, 50, 70 | Radiometer America, Inc. | 1996-10-29 | 147 | 0 |
| K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER | Radiometer America, Inc. | 1996-10-24 | 129 | 1 |
| K961354 | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) | Radiometer America, Inc. | 1996-06-14 | 67 | 0 |
| K961355 | MULTICHECK | Radiometer America, Inc. | 1996-06-14 | 67 | 0 |
| K952725 | MULTICHECK | Radiometer America, Inc. | 1996-02-20 | 251 | 0 |
| K954612 | ABL SYSTEM 625, 615, 605 | Radiometer America, Inc. | 1995-11-09 | 35 | 1 |
| K952621 | EML105 ELECTROLYTE METABOLITE ANALYZER | Radiometer America, Inc. | 1995-10-17 | 131 | 0 |
| K951241 | HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE | Radiometer America, Inc. | 1995-10-07 | 222 | 0 |
| K951240 | JUSTONE | Radiometer America, Inc. | 1995-10-07 | 222 | 0 |
| K952637 | QUALICHECK 4 GLUCOSE | Radiometer America, Inc. | 1995-09-05 | 88 | 0 |
| K936305 | SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES | Radiometer America, Inc. | 1995-07-13 | 569 | 9 |
| K943882 | ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM | Radiometer America, Inc. | 1995-03-10 | 213 | 1 |
| K944753 | SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP | Radiometer America, Inc. | 1995-02-24 | 151 | 0 |
| K935655 | ABL5 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1994-05-27 | 184 | 1 |
| K935121 | ABL SYSTEM 620 | Radiometer America, Inc. | 1994-05-27 | 212 | 0 |
| K935120 | EML 100 | Radiometer America, Inc. | 1994-04-26 | 181 | 0 |
| K935515 | MULTICHECK(TM) | Radiometer America, Inc. | 1994-04-26 | 162 | 0 |
| K935566 | SENSI-CAL AMCO AEPA-1 | Radiometer America, Inc. | 1994-03-29 | 131 | 0 |
| K924802 | CALIBRATION VERIFICATION KIT OR CVK | Radiometer America, Inc. | 1993-03-09 | 166 | 0 |
| K923045 | SENSITITRE SUSCEPTIBILITY PLATES | Radiometer America, Inc. | 1993-03-09 | 258 | 0 |
| K923342 | MICROBACT SOLID PLATE SYSTEMS | Radiometer America, Inc. | 1992-09-22 | 98 | 0 |
| K922922 | ABL50 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1992-08-28 | 72 | 1 |
| K912444 | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM | Radiometer America, Inc. | 1992-02-18 | 260 | 0 |
| K914166 | ABL505 BLOOD GAS & ELECTROLYTE SYSTEM | Radiometer America, Inc. | 1992-01-28 | 133 | 1 |
| K915399 | QUALICHECK 4 | Radiometer America, Inc. | 1992-01-02 | 34 | 0 |
| K910827 | ABL520 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1991-07-09 | 132 | 0 |
| K904513 | ABL510 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1990-12-13 | 72 | 0 |
| K904733 | QUALICHECK 3 | Radiometer America, Inc. | 1990-11-02 | 16 | 0 |
| K900333 | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. | Radiometer America, Inc. | 1990-04-16 | 83 | 0 |
| K896514 | QS90 SMOOTH E ARTERIAL BLOOD SAMPLER | Radiometer America, Inc. | 1990-01-23 | 70 | 0 |
| K895181 | ABL500 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1989-10-06 | 56 | 1 |
| K893587 | OXIMETER | Radiometer America, Inc. | 1989-09-05 | 119 | 0 |
| K894776 | SENSITITRE INDOLE REAGENT | Radiometer America, Inc. | 1989-08-31 | 35 | 0 |
| K894110 | QUALICHECK 2 | Radiometer America, Inc. | 1989-08-03 | 52 | 0 |
| K890057 | SENSITITRE AUTO ID PLATE AP80 | Radiometer America, Inc. | 1989-06-09 | 154 | 0 |
| K871353 | OXIMETER | Radiometer America, Inc. | 1987-06-08 | 63 | 0 |
| K860057 | ABL330 ACID BASE LABORATORY | Radiometer America, Inc. | 1986-03-05 | 58 | 0 |
| K853990 | OSM3 HEMOXIMETER | Radiometer America, Inc. | 1985-12-30 | 94 | 0 |
| K844295 | ABL300 ACID BASE LABORATORY | Radiometer America, Inc. | 1984-12-10 | 34 | 0 |
| K833696 | ACID BASE LABORATORY ABL4 | Radiometer America, Inc. | 1984-01-18 | 92 | 0 |
| K831034 | QUALISTICK ARTERIAL BLOOD SAMPLER | Radiometer America, Inc. | 1983-05-18 | 48 | 0 |
| K830805 | KNAI SODIUM POTASSIUM ANALYZER | Radiometer America, Inc. | 1983-04-08 | 25 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda